Kornimate/medical-research-clean huggingface dataset:
studying biomarkers in samples from patients with high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in samples from patients with high-risk neuroblastoma.

objectives: * to establish telomere length measurement by quantitative polymerase chain reaction (qpcr) as an alternative lengthening of telomeres (alt) detection method in neuroblastoma (nb). * to determine the frequency of alt in high-risk nb and the characteristics of alt+ nb. * to establish c-circle (extra-chromosomal telomeric dna circles) level as a marker of alt activity in nb. * to evaluate the prognostic significance of alt in nb. * to evaluate the utility of the c-circle assay for the detection of circulating tumor dna in nb patients with an alt+ tumor. outline: archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and c-circle levels by pcr. results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).

Eligibility criteria:
disease characteristics: * snap-frozen neuroblastoma (nb) tumors collected at diagnosis (objectives 1 to 3) * high-risk stage 3 or 4 nb and mycn non-amplified, i.e., exclude stage 4 infants who are not high-risk * up to five high-risk (\> 18 months, unfavorable histology) stage 3/mycn non-amplified tumors * patients preferably treated on protocol cog-a3973 or similar protocols with myeloablative therapy * at least 3 years of follow-up for those with no event (current evidence suggests that alt+ nbs often relapse late, i.e., 2 years or longer from diagnosis) * nb tumor dna collected at diagnosis (objectives 2 \& 3) * high-risk stage 3 or 4 nb as for objective 1, except for mycn status * stage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of mycn-amplified and non-amplified tumors * frozen serum from nb patients (objective 5; 2nd stage of project) * paired serum obtained at diagnosis from patients with alt+ or alt- tumors identified in objective 2 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage 4s neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma recurrent neuroblastoma regional neuroblastoma
a study assessing the reg1 anticoagulation system compared heparin in subjects with acute coronary syndrome

Conditions: Acute Coronary Syndrome (ACS)

Summary: the purpose of this study is to evaluate the safety and efficacy of the reg1 anticoagulation system in acute coronary syndrome (acs) patients undergoing cardiac catheterization.

primary outcome bleeding secondary outcome ischemia

Eligibility criteria:
inclusion criteria: * chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization; * at least one of the following criteria are met: 1. new or presumably new st-segment depression of at least 1 mm or transient (30 minutes) st-segment elevation of at least 1 mm in 2 contiguous leads; 2. elevated troponin i, t, or creatine phosphokinase-mb isoenzyme level within 24 hours of signing consent as defined by the universal mi definition 3. documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction exclusion criteria: * acute st-segment elevation myocardial infarct * anticipated inability to perform angiography within 24 hours of dosing * evidence of clinical instability * contraindications to anticoagulant use * recent cardiac intervention * clinically abnormal laboratory or test findings during screening * subject is pregnant or lactating

Keywords: acs acute coronary syndrome catheterization
evaluate the safety and efficacy of a steerable catheter in the treatment of vascular interventional access

Conditions: Peripheral Vascular Diseases

Summary: this is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. the total enrollment number is 68. in the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. evaluate the safety and efficacy of the product, by the observation and record the relative index of subjects intraoperative and postoperative (discharge) before and after 30 days .

this is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. the total enrollment number is 68. in the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. evaluate the safety and efficacy of the product, by the observation and record the relative index(like catheter compliance, catheter directivity, and catheter visibility under x ray) of subjects in the procedure, telephone follow up at 30 days investigate the subjects healthy condition.

Eligibility criteria:
inclusion criteria: * age from 18 to 80, male or female. * complying with the standard of peripheral vascular interventional operation treatment , complying with the standard treatment of vascular angiogram, need to establish vascular interventional treatment access. * the subject who is able to understand the test purpose, voluntarily join this clinical trial with informed consent forms. exclusion criteria: * patients with cerebrovascular accident or major gastrointestinal bleeding in six months unable to carry out antithrombotic therapy because of having contraindications to antiplatelet agents and anticoagulants and have haemorrhage tendency * hypohepatia, hematuria, deep vein thrombosis, and/or receiving the immunosuppressant therapy * the distal target vessel blood flow low may produce thrombosis * the women who pregnancy, lactation and can't contraception during the trial period * patients has been involved in other drugs or medical devices clinical trials related to treatment of the target lesion or has been involved in other drugs or medical device clinical trials but have not reached the primary endpoint of the study * patients unable or unwilling to participate in this trial * the researcher determine the patient is not suitable to participate in clinical research
hyperemic efficacy of iv adenosine in hfref

Conditions: Heart Failure With Reduced Ejection Fraction; Coronary Artery Disease

Summary: little is known about the hyperemic efficacy of iv adenosine as well as safety in patients with heart failure with reduced ejection fraction (hfref) because they were excluded from the major ffr studies. we will evaluate the feasibility and hyperemic efficacy of iv adenosine in patients with hfref in comparison with ic nicorandil for invasive physiological assessment using a coronary pressure wire.

little is known about the hyperemic efficacy of iv adenosine as well as safety in patients with heart failure with reduced ejection fraction (hfref) because they were excluded from the major ffr studies. we will evaluate the feasibility and hyperemic efficacy of iv adenosine in patients with hfref in comparison with ic nicorandil for invasive physiological assessment using a coronary pressure wire. patients with an angiographically intermediate lesion (40-70% diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection fraction ≤40% will be prospectively enrolled. ffr under the various hyperemic stimulation using iv adenosine 140 \& 180, ic adenosine, and ic nicorandil will be measured sequentially.

Eligibility criteria:
inclusion criteria: * angiographically proven epicardial intermediate stenosis (40-70%) * echocardiographically proven lv dysfunction (lvef ≤40%) exclusion criteria: * infarct-related artery, less than 2 weeks * killip class 3 and 4 * bronchial asthma * second degree or third degree av block * any contraindications to adenosine

Keywords: heart failure with reduced ejection fraction intermediate coronary stenosis adenosine hyperemia
protective effect of early high dose statins on cardiovascular and renal events in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: registration of all acs patients (stemi and nstemi) admitted to the cardiology ward and scheduled for early invasive strategy. the aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

statin-naive patients and those on statin therapy with acs who are admitted to the cardiology ward of our public (national health service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. during hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. clinical follow-up and hematological analysis are done 1 month after discharge. a second follow-up, either clinical or by telephone, is done 1 year after discharge.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome (st elevation and non st elevation) * early invasive strategy exclusion criteria: * contraindication to statin therapy * refusal of consent

Keywords: stemi nstemi acute kidney injury renal function statin therapy
inspiratory muscle training (emi) on inspiratory muscle strength, pulmonary capacity and performance in soccer players

Conditions: Breathing Exercises: Inspiratory Muscle Training

Summary: the training of the respiratory muscles seems to be fundamental in people who require a high physical demand. there is abundant scientific evidence that relates the respiratory variables and the limitation to exercise. the published studies are athletics and cycling, however it is scarce in football. objective. to assess the effects of inspiratory muscle training on lung function and sports performance in soccer players.

objective. to assess the effects of inspiratory muscle training (imt) on lung function, inspiratory muscle strength and athletic performance in soccer players. method. participants will be randomized into two groups: experimental and sham . the two groups will perform a protocol of 8 weeks of training (6 days / week) with the powerbreathe device. the eg will use progressive resistance loads up to 80% of the mip, while the sg will use the device with a minimum load (20% pimax) during the 8 weeks. all participants will have the following tests before and after the intervention and 3 months after the end of the program: spirometry (fvc, fev1), pimax, biophotogrammetry, and fit 30/15 test. for the statistical analysis, a 2-factor variance analysis will be performed for repeated measures and pearson's correlations. the statistical significance will be set with a value of p \<0.05. the effect size will be calculated using the partial eta-square.

Eligibility criteria:
inclusion criteria: * soccer players exclusion criteria: * soccer players with disabilities
expression of dmbt1 in colorectal cancer patients

Conditions: DMBT1 Protein, Human; Colorectal Cancer

Summary: although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. the 5-year survival is about 55% often due to a late detection. then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease. preliminary work have reported variations in the expression of dmbt1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. the goal of this study is to study by mass spectrometry (ms), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.


Eligibility criteria:
inclusion criteria: * for colon cancer: patients surgically treated for colorectal cancer at the group of hospitals of the catholic institute of lille. * for adenomatous polyps : patients treated for adenomatous polyps at the group of hospitals of the catholic institute of lille. * for controls: patients surgically treated for diverticular disease at the group of hospitals of the catholic institute of lille. exclusion criteria: * none

Keywords: dmbt1 expression colorectal cancer
breast-10: three-weekly versus weekly first-line chemotherapy for metastatic or locally advanced breast cancer

Conditions: Breast Cancer

Summary: some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. the purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin. patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine. all patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.

Eligibility criteria:
inclusion criteria: * histological diagnosis of breast cancer * inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy * age \< 70 years * ecog performance status \< 2 * written informed consent exclusion criteria: * previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix) * previous treatment with docetaxel * symptomatic brain metastases * neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl * creatinine \> 1.25 x the upper normal limits * got and/or gpt \> 1.25 x the upper normal limits in absence of hepatic metastases * got and/or gpt \> 2.5 x the upper normal limits in presence of hepatic metastases * bilirubin \> 1.5 x the upper normal limit * any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * inability to provide informed consent * inability to comply with follow-up

Keywords: anthracycline pre-treated chemotherapy first-line metastatic breast cancer locally advanced breast cancer
the effects of probiotics in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. there has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. the mechanism of this improvement is currently unknown. we propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the t regulatory cell--which can suppress the activity of allergic disease.

the central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of t regulatory (treg) cells. we specifically hypothesize that the probiotic mixture that induces treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing treg activity in vivo. 1. we will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. we will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the scoring atopic dermatitis (scorad) index. we specifically hypothesize that probiotics will clinically improve the disease. 2. we will assess whether probiotic mixtures induce the development of t regulatory cells in patients with atopic dermatitis. a. we will measure the relative levels of tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter treg development in vivo, and whether these changes correlate with improvement in clinical scores. primary outcomes will be measurements of gene expression and absolute increases in cell population. we specifically hypothesize that probiotics will increase treg activity. b. we will also determine if all patients' tregs have in vitro responses to probiotics. this data will be used to correlate whether clinical responders in the study also have strong in vitro responses.

Eligibility criteria:
inclusion criteria: * age between 6 months to 3 years * physician diagnosis of moderate to severe atopic dermatitis as defined by the hanifin and rajka criteria * ability to take enterally commercially available probiotics by powder form added to food or drink * ability to undergo venipuncture or dermal puncture (if less than 1 year old) exclusion criteria: * prior exposure to probiotics * current antibiotic administration * known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency * absence of t regulatory cell induction by probiotic bacteria on initial laboratory assessment * any other condition in which the investigators involved in the study determine potential subject is unsuitable for the study

Keywords: atopic dermatitis probiotics t regulatory cells
observational study to assess the reliability and validity of the mlymt and mlsdt

Conditions: Retinitis Pigmentosa; Retinal Dystrophy

Summary: this is a prospective multi-center observational study to assess the reliability and validity of the multi-luminance y-mobility test (mlymt) and multi-luminance shape discrimination study (mlsdt) main outcome measures: (i) performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (rp) on mlymt and mlsdt at multiple luminance levels and (ii) reliability and content validity of mlymt and mlsdt.

two assessment visits will be conducted in order to evaluate functional visual performance in severely vision impaired subjects with rp and normally sighted subjects. two visits will occur at week 0 and week 4 with functional vision assessments occurring at both visits in order to assess visit-to-visit variability. for the mlymt, navigational vision will be assessed using each eye and binocularly at up to 6 different light levels (range 0.3 to 100 lux). subjects will also perform the multi-luminance shape discrimination test (mlsdt) which assesses near object recognition under different lighting levels. mlymt and mlsdt performance will be evaluated together with best corrected visual acuity (bcva), visual field (vf) and responses to visual function questionnaires. subjects will be assigned to one of two cohorts based on presence or absence of rp in addition to bcva performance.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. able to comprehend and give informed consent. 3. able to comply with testing and all protocol tests. 4. eligible for 1 of 2 cohorts listed below: cohort 1: normally sighted participants with clinically normal ocular findings and bcva better than logmar 0.3 (as confirmed by etdrs letter score \> 73) in each eye cohort 2: severely sight impaired participants with bcva no better than logmar 1.6 in better seeing eye, and worse than logmar 1.9 in the worse seeing eye, and a clinical diagnosis of advanced rp exclusion criteria: 1. concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months 2. presence of any condition other than rp disease that impairs visual acuity or visual fields e.g., visually significant cataract or visual field loss in glaucoma 3. presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke 4. individuals who refuse or are incapable of performing mobility testing 5. individuals with retinal prosthesis (such as argus-ii) 6. participation in nanoscope studies ntxmco-002 (restore) or ntxmco-004 (starlight)

Keywords: retinitis pigmentosa inherited retinal diseases eye diseases retinal degeneration mobility test multi-luminance y- mobility test
analysis of the pachychoroid phenotype in an asian population

Conditions: Pachychoroid Disease

Summary: the understanding of pachychoroid phenotype is incomplete. it is important to understand the risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease phenotype, to guide appropriate management of these patients.

the progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well established and the pathophysiology of these phenotypes remains unknown: specifically if the occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal attenuation. a longitudinal study of the pachychoroid phenotype will provide much needed information regarding the natural history of the pachychoroid phenotype. secondly, a detailed chronicle of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the pathogenesis, and facilitate the development of disease modulation strategies.

Eligibility criteria:
inclusion criteria: 1. presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least one eye. 2. subfoveal choroidal thickness \>300 microns on enhanced depth imaging optical coherence tomography for at least one eye 3. male or female patients above 45 years of age 4. willingness to undergo pupil dilation, and protocol- required procedures for both eyes 5. willing to provide written informed consent exclusion criteria: 1. presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including spectral domain- optical coherence tomography during the study period 2. pregnant or nursing women

Keywords: pachychoroid neovasculopathy pachychoroid choroidal vasculopathy
effectiveness of adhesive containing mdpb

Conditions: Secondary Caries

Summary: 9 general practices in the netherlands were provided with two composite resin adhesives, each for a period of 9 months. one contained mdpb (adhesive p), and the other one was used as a control (adhesive s). patient's age, ses, and caries risk, as well as tooth type/number, reason for restoration placement, used restorative material and bonding agent, and affected surfaces were recorded. all interventions carried out on these teeth in the next 6 years were extracted from the electronic patient records, along with their date, type, reason, and surfaces. two dependent variables were defined: general failure, and failure due to secondary caries. all data handling and statistical analyses were carried out in r 4.0.5.


Eligibility criteria:
inclusion criteria: * needing at least one dental restoration exclusion criteria: * opted out of data collection